GENERIC NAME OF THE MEDICINAL PRODUCT:

Valsartan Tablets USP 40mg
Valsartan Tablets USP 80mg
Valsartan Tablets USP 160mg
Valsartan Tablets USP 320mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Valsartan Tablets USP 40mg
Each film coated tablets contains:
Valsartan USP…………………….…40mg
Excipients………………………………………q.s.
colures: Iron Oxide Yellow

b) Valsartan Tablets USP 80mg Each film coated tablets contains:
Valsartan USP………………….80mg
Excipients……………………………………. q.s.
colures: Red Oxide iron

c) Valsartan Tablets USP 160mg
Each film coated tablets contains:
Valsartan USP…………………….…160mg
Excipients………………………………………q.s.
colures: Iron Oxide Yellow

d) Valsartan Tablets USP 320mg
Each film coated tablets contains:
Valsartan USP……………………….320mg
Excipients…………………………………………. q.s.
colures: F&D Blue (Indigo Carmine).

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension in adults.
Valsartan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan monotherapy.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Valsartan Tablets USP Technical Specification:

Product Name:
 Valsartan Tablets USP
Brand Name: Generics
Strength: 40mg, 80mg, 160mg, 320mg
Dosage Form: Tablets (Film-coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s, 500s, 1000s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-hypertensive, Diuretics, Enzyme Inhibitor, Cardiovascular System.
Indication: Valsartan is indicated for the treatment of hypertension, to lower blood pressure.
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Valsartan Tablets USP 40mg
  • Valsartan Tablets USP 80mg
  • Valsartan Tablets USP 160mg
  • Valsartan Tablets USP 320mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Valsartan Tablets USP 40mg
Each film coated tablets contains:
Valsartan USP…………………….…40mg
Excipients………………………………………q.s.
Colures: Iron Oxide Yellow

b) Valsartan Tablets USP 80mg
Each film coated tablets contains:
Valsartan USP………………….80mg
Excipients……………………………………. q.s.
colures: Red Oxide iron

c) Valsartan Tablets USP 160mg
Each film coated tablets contains:
Valsartan USP…………………….…160mg
Excipients………………………………………q.s.
colures: Iron Oxide Yellow

d) Valsartan Tablets USP 320mg
Each film coated tablets contains:
Valsartan USP……………………….320mg
Excipients…………………………………………. q.s.
colures: F&D Blue (Indigo Carmine).

THERAPEUTIC INDICATIONS:

  • Treatment of essential hypertension in adults. Valsartan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan monotherapy.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.
Attach dispensing label as per end county.